Echo-Focusing in Patients With Treatment-Resistant Neurologic and Psychiatric Indications (EF001)

Inclusion criteria

• . Men and women ≥ 20 and ≤ 80 years of age.
• . Patients who are able and willing to give consent and physically and practically able to attend study visits, as determined by both study psychiatrist and the surgeon.
• . DSM-V diagnosis of major depressive disorder (MDD), or bipolar disorder with predominant depressive symptoms.
• . At least 5-year illness history of the primary disorder and at least 6 months since the onset of the first episode of major depression.
• . A minimum score of 20 on the Hamilton Depression Rating Scale (HAMD) when depressed (patients with bipolar disorder may be rapid cycling, but must have at least 2 weeks of major depression at the time the HAMD is conducted).
• . Medication-refractoriness as determined by an adequate dose and duration of standard psychiatric treatments (including psychotherapy and/or pharmacology) as determined by a psychiatrist associated with the study. Including specifically:
• . Failed to respond or tolerate adequate trials of three or more medications accepted as first line therapies in the treatment of depression.
• . Failed to respond or tolerate augmentation with or combination of at least 2 medications known to be first line treatments for depression.

Exclusion criteria